The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers (MUPAW)

The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers: A Randomized Controlled Trial

Objective: To evaluate the effects of different types of music (instrumental Turkish music and Western music without lyrics) played during wound care on pain, anxiety, and patient satisfaction among individuals with venous ulcers.

Methods: In this randomized controlled trial, 97 patients with venous ulcers were assigned to three groups: Western Music (n=32), Turkish Music (n=32), and Control (n=33). Patients in the music groups listened to their assigned music during routine wound dressing, while all patients received individualized, evidence-based care. Pain and anxiety were measured with VAS and STAI before, during, and after dressing, and patient satisfaction was assessed with VAS post-procedure.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Venous Leg Ulcer
• Intervention / Treatment: Other: Turkish Music Intervention; Other: Western Music Intervention

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
    • İzmir Katip Çelebi Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients attending the outpatient clinic with venous leg ulcers (CEAP classification: C6 - active ulcers)
• Age between 18 and 65 years
• Absence of neuropathy
• Willingness to listen to music and voluntary participation
• Literacy (able to read and write)
• No visual or hearing impairments
• No cognitive deficits; fully oriented to time, place, and person
• Turkish-speaking
• No formal music education

Exclusion Criteria:

• Diagnosis of diabetes or diabetic foot
• Use of analgesic medications prior to or during routine wound care
• Individuals younger than 18 or older than 65 years
• Patients with psychiatric disorders
• Individuals with intellectual disabilities
• Patients with severe anxiety levels (STAI-S score 60-79 indicating severe anxiety)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: Turkish music; Music Intervention	Other: Turkish Music Intervention; The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication). To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.; Other Names: music therapy
Experimental: Western music; Music Intervention	Other: Western Music Intervention; The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication).[22] To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.; Other Names: Music therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measured by the Visual Analog Scale (VAS)	Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS), where higher scores indicate more severe pain.	Immediately before wound dressing; Periprocedural period; Immediately after wound dressing
State anxiety level measured by the State Anxiety Inventory (STAI-S) score	State anxiety will be assessed using the State Anxiety Inventory (STAI-S), a 20-item validated self-report scale that measures situational (state) anxiety. Scores range from 20 to 80, with higher scores indicating greater anxiety levels.	Before the wound dressing procedure; Immediately after the wound dressing procedure

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Music Therapy; Venous Leg Ulcer; Wound Dressing; Nursing Intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain; Anxiety Disorders; Varicose Ulcer; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: 0553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the primary outcome results will be shared.
• IPD Sharing Time Frame: Beginning 1 year and ending 2 years after the publication of results
• IPD Sharing Access Criteria: Data will be made available upon reasonable request to the corresponding author. Requests must include a research proposal and will be reviewed for scientific merit and ethical compatibility.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No